Tonometry Precision and Accuracy During PROSE Scleral Lens Wear: A Pilot Study

Completed · Not applicable

Conditions studied: Intraocular Pressure and PROSE Lens

In brief

The goal of this research is to determine the reproducibility of measurements of intraocular pressure (IOP) when a scleral lens is on the eye. The PROSE device (PD) is a specialized scleral lens that is filled with preservative-free saline and then applied to the eye in order to treat a variety of ocular conditions. The fit of the PROSE device is optimized to land gently on the conjunctival tissue overlying the sclera while completely vaulting the cornea and limbus without touch. Because the PROSE device vaults and therefore covers the cornea, measuring IOP during PROSE wear is challenging as traditional techniques rely on corneal contact (i.e. Goldmann tonometry, iCare, pneumatonometry, etc.). Measuring IOP before insertion and after removal of the PROSE device likely does not correspond to the true IOP when the PROSE device is actively on the eye. This is a prospective study of the reproducibility of three non-traditional means of IOP measurements: scleral tonopen, scleral pneumatonometry, and transpalpebral Diaton tonometer. Evaluating these means of measurements may be important for future studies investigating the effect of PROSE wear on intraocular pressure.

Key facts

Study ID

NCT04308941

Run by

Boston Sight

People needed

30

Starts

2020-04-13

Expected to finish

2021-04-27

Last updated by the study team

2023-11-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Written Informed Consent has been obtained prior to any study-related procedures taking place
• Written documentation has been obtained in accordance with the relevant county and local privacy requirements, where applicable
• Male or female, 18 years of age and older prior to the initial visit
• Is an established wearer of PROSE in both eyes; without fenestrations or channels; with diameter equal to or greater than 18.0 mm
• Upon examination by the investigator, there is adequate exposure of the sclera as required for IOP measurements with the planned device
• In the opinion of the investigator, the subject has the ability to follow study instructions
• In the opinion of the investigator, the subject has the ability to complete all study procedures and visits

You may not qualify if…

• Is aphakic (i.e., missing their natural lens inside the eye)
• Is currently participating in any other type of eye-related clinical or research study
• Is pregnant or nursing as reported by the subject
• Less than 18 years of age
• Has a condition or is in a situation which, in the investigator's opinion, may put the subject at significant risk, may confound study outcomes, or may significantly interfere with the subject's participation in the study
• Has had previous ocular surgery within the past 12 weeks
• Has a diagnosis of glaucoma, glaucoma suspect, ocular hypertension or prior glaucoma surgery

Where it is running

• BostonSight — Needham, Massachusetts, United States

Full record on ClinicalTrials.gov

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